InsightersTM Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; InsightersTM Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; InsightersTM Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; InsightersTM Insight Workstation iS-PF1.
Shenzhen Insighters Medical Technology Co., Ltd.The InsightersTM Single-use Bronchoscope System is a medical imaging device consisting of disposable flexible bronchoscopes and a compatible workstation display. It provides clear, real-time images for clinicians to observe, diagnose, and treat diseases affecting the trachea, bronchi, and lungs. The device enhances clinical workflow with its portability, image clarity, and single-use design to reduce risk of infection.
Intended Use
The Insighters Single-use Bronchoscope System provides images for the observation, diagnosis and treatment of the trachea, bronchus and lung area; indicated for diseases of the trachea and bronchi; for use in hospitals by trained clinicians.
Technology
The system consists of a single-use flexible video bronchoscope with an insertion part and operation part, connected to a reusable Insight Workstation that powers the bronchoscope and processes image data from a CMOS sensor illuminated by integrated LED light. The bronchoscope features a working channel for accessory use, is sterilized by ethylene oxide, and designed for ease of use, portability, and clear image delivery.
Performance
Non-clinical testing demonstrated compliance with electrical safety (IEC 60601-1 series), optical performance (ISO 8600 series), biocompatibility (ISO 10993 series), mechanical reliability, color performance, usability, sterility, and thermal safety. The device showed substantial equivalence to a predicate device without clinical study required.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/16/2024
8 months - 2
FDA Approval
5/28/2025
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